The By-Band-Sleeve study aims to find out the best type of operation to treat obesity. There are three operations routinely offered to patients in the UK: gastric Band surgery, gastric Bypass surgery and Sleeve gastrectomy surgery. There are advantages and disadvantages with each operation.

Can I Take Part?

If you are offered surgery at one of the hospitals taking part in the By-Band-Sleeve study you will have an opportunity to learn more about the study and discuss it with the local research team. You can then decide if you want to take part in the study.

Before you make your decision about whether you wish to take part you will have appointments with a consultant surgeon and a research nurse. We will ask your permission to audio-record these appointments so that we can evaluate the information you are provided with.

During these appointments, the doctor and nurse will ask you more questions about yourself and they will explain each of the operations in detail. They will also discuss participation in the By-Band-Sleeve study. The appointment will go ahead, whether or not you agree to the audio-recording.

What operation will I receive if I take part?

Patients who take part in the study will be treated with gastric Band surgery, gastric Bypass surgery or Sleeve gastrectomy surgery. All three operations are standard treatments for severe and complex obesity. At the moment, nobody knows which is best and we are doing this study to compare them. The type of operation you have will be decided randomly; you could receive any one of the three operations. The method of selecting the operation is designed to ensure that very similar patients receive each operation. This is the only way that allows us to compare the three operations fairly.

If you decide to take part in the study, your operation will take place in the same way that it would normally. In addition we may audio- and video-record your operation. This will allow us to assess whether all the operations are performed in a similar way.

What will I have to do?

If you are interested in participating in the By-Band-Sleeve Study, the research nurse will arrange to meet you after your appointment with the surgeon. This will give you the opportunity to ask further questions about each operation and what the study entails.

If you decide to take part in the study, you will be asked to attend the hospital for follow-up four weeks after your operation, and then at six months, and one, two and three years after you joined the study. These visits will be arranged to coincide with your normal hospital follow-up wherever possible. In addition to blood samples that will be taken as part of your clinical care, you will be asked to give a small sample of blood before your operation and again three years after your operation for research purposes.

We are very interested to know how people undergoing surgery for obesity recover after the operation, about the health services they use and other costs incurred during participation in the By-Band-Sleeve study. We will ask you to fill in questionnaires before your operation is decided, in the week before your operation, four weeks after your operation, and then at six months, one year, two years and three years after you joined the study. You will have the option to complete these online using a personal secure login.

We would also like you to complete a patient resource use diary for the full duration of your time in the study (i.e. up to your follow-up at three years). We will contact you regularly (approximately every four months) to send you a new diary and ask you to return the one you have been using. You will also have the option to complete the diary online.

Some people will also be invited to meet one of our researchers to be interviewed in more detail about their experiences. If you agree to this you will be asked for your written consent.

If you would like to take part in the By-Band-Sleeve study, you will be asked to confirm by signing a consent form. You will be given a copy to keep for your records.

Expenses

Travel expenses will be available for any visit you make to the hospital for the study which would NOT be expected to occur as part of normal patient care

What alternatives are there to taking part in the study?

If you decide not to take part in the By-Band-Sleeve study, then you will be offered the usual treatment at this hospital and your care will proceed as usual.

If you do not want to take part, we will also ask if you are willing for some information on your health and the operation you undergo to be collected and used. You will also be asked to complete a simple questionnaire before your surgery, and to have one follow-up discussion at three years (a phone call and the same simple questionnaire).

Disadvantages and Benefits

What are the possible disadvantages and risks of taking part?

There should be no additional physical risk to you during your involvement in the By-Band-Sleeve study because all three operations offered are standard treatments for severe and complex obesity.

Taking part in this study may involve being audio-recorded in the clinic and being interviewed. It will also involve completing health questionnaires and attending follow-ups. If you felt the interview was causing undue distress or emotional discomfort, you would be able to end the interview at any time.

If at any time you change your mind, you may withdraw from the study without giving any reason and without your medical or legal rights being affected.

Private medical or life insurance may be affected by taking part in a study and, if applicable, you should check with your insurance company before taking part.

What are the possible benefits of taking part?

The information we will get from the study will be very helpful to the NHS and future patients needing surgery for obesity. Some people find that undergoing interviews helps them talk through their situation and this is comforting. Some others enjoy being part of research studies because of the close contact with research staff and the opportunity to share their opinions and experiences of obesity surgery.

Summary of Current Treatments

It is difficult to be precise about some of the risks and benefits of the treatments because not much research has been done. That is why we are carrying out the By-Band-Sleeve study - to ensure that we have this information for the future. We have made ‘best-guess’ estimates based on world-wide research. The table summarises the possible advantages and disadvantages of each treatment.

Treatment

What it entails

Possible advantages

Band surgery

Laparoscopic adjustable gastric band

Surgical operation taking less than 1 hour in which a band is inserted around the top of the stomach to reduce its size. An overnight stay in hospital is usually required.

Follow up schedule of clinic visits for band adjustments are required. There may be up to 10 visits in the first two years. Patients are required to take long term vitamin and mineral tablets.

Requires significant dietary modification by the patient.

Weight loss is gradual over a long period (2-3 years).

If significant weight loss is achieved, health problems such as diabetes may resolve.

Bypass surgery

Laparoscopic gastric Bypass

Surgical operation taking 1 to 2 hours in which a small pouch is made in the top of the stomach and a loop of bowel connected to this pouch to bypass the rest of the stomach. A 1 to 3 day hospital stay is required.

Follow up schedule of clinic visits at 4 weeks, 3, 6 and 12 months after surgery and annually thereafter. Patients are required to take long term vitamin and mineral tablets and also require regular 3 monthly vitamin B12 injections.

Requires significant dietary modification by the patient.

Rapid weight loss in first 6 months which slows then stabilises at 18 months. At this stage weight may be regained and can be significant in about 1 in 5 patients.

If significant weight loss is achieved, health problems such as diabetes may resolve.

Sleeve surgery

Laparoscopic Sleeve gastrectomy

The operation reduces the size of the stomach by about 75%, creating a narrow tube. It is done by stapling down the stomach and removing the remainder of the stomach. The new small stomach still works in the same way but will feel full quicker.

Follow up schedule of clinic visits at 4 weeks, 3, 6 and 12 months after surgery and annually thereafter. Patients are required to take long term vitamin and mineral tablets and also require regular 3 monthly vitamin B12 injections.

Requires significant dietary modification by the patient.

Patients experience weight loss over the first 12 months, which tends to plateau thereafter.

If significant weight loss is achieved, health problems such as diabetes may resolve.

Treatment

Possible short term disadvantages

Possible longer term disadvantages

Band surgery

Laparoscopic adjustable gastric band

Risks related to any operation: e.g. blood loss/clots, infection, death – very rare: less than 1 in 1000.

There is a 1 in 100 chance that further surgery is required shortly after first operation surgery because of problems swallowing.

Problems with the band that may require further surgery occur in about 1 in 15 patients. These are generally straight forward to fix.

Bypass surgery

Laparoscopic gastric Bypass

Risks related to any operation: e.g. blood loss/clots, infection, death – rare: less than 3 in 1000.

There is a 3 in 100 chance that further surgery is required shortly after the first operation because of problems specific to gastric Bypass e.g. leakage or bleeding from joins in the bowel.

Problems with the bypass that may require further surgery can occur in about 1 in 25 patients. These problems whilst less common than after a gastric band can be more serious.

Patients are required to take long term vitamin and mineral tablets.

Sleeve surgery

Laparoscopic sleeve gastrectomy

Risks related to any operation: e.g. blood loss/clots, infection, death – rare: less than 3 in 1000.

There is a 2 in 100 chance that significant problems specific to Sleeve gastrectomy are experienced e.g. leakage or bleeding along the line of staples. This may require a second operation or a prolonged stay in hospital.

Problems with the sleeve that may require further surgery can occur in about 1 in 25 patients. These problems whilst less common than after a gastric band can be more serious.

What if there is a Problem?

We have no reason to believe that you will be placed at any greater risk by taking part in this research study. It carries no risk of physical or significant psychological harm. However, if something goes wrong and you are harmed by taking part in this research study, there are no special compensation arrangements.

If you are harmed due to someone’s negligence, then you may have grounds for legal action, but you may have to pay for it. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, the normal National Health Service complaints mechanisms will still be available to you.

Will my taking part in the Study be kept Confidential?

All information which is collected about you during the course of the research will be kept strictly confidential. This will include details such as your name, address and NHS number, to allow us to keep in touch with you during your participation in the research. We will record information about your health which is essential to allow us to compare the three operations. All the information collected will be stored in a secure database held at the co-ordinating centre, and will only be accessed by authorised members of staff involved in the research. This includes the hospital research team and staff at the coordinating centre who are managing the research and will be responsible for aspects of your follow-up such as sending you questionnaires. Information about your health and participation in the research will be linked to your personal data using a unique study number. The personal data will be stored separately in the database and in locked filing cabinets.

Your medical notes will need to be seen by authorised members of the hospital research team so they can collect information about your health needed for this research study. With your consent, your GP will also be informed that you are taking part in the research study. Your GP may be asked to provide information from your records which is required for the research. Occasionally, other members of NHS staff or research staff may need to check your medical records. This will be done by NHS staff or by researchers who are bound by the same rules of confidentiality as all NHS staff. The confidentiality of your medical records will be respected at all times. Under no circumstances will you be identified in any way in any report arising from the study.

With your consent, after you leave the study we would still like to know how you are progressing using information collected routinely in the NHS and information held routinely by the NHS Information Centre. Information will be obtained from the NHS Information Centre’s ‘Medical Research Information Service’. Any information received in this way remains confidential and will only be used for the purpose of this research.

What will happen if I don't want to carry on with the Study?

If you decide not to carry on with the study, you can withdraw at any time and without giving a reason. A decision to withdraw at any time or a decision not to take part will not affect the standard of care you receive. Exactly what happens depends on when you withdraw.

If you withdraw before the operation, you will be offered the usual treatment at your hospital. However we would like to continue to follow your progress using information collected routinely in the NHS as this will be invaluable to our research.

If, after the operation, you do not want to take part any further, your care will continue in the usual way. We will ask you to tell us what you would like us to do with any information and blood samples that have already been collected. Information and blood samples collected up to the point at which you decide to withdraw is still valuable for the study. Therefore, we will ask whether you want the information and samples destroyed, or whether we can use the information and samples but without requiring any further contact with you. We will also ask whether we can continue to follow your progress using standard NHS records, without contacting you.

After the Study

What will happen to any samples I give?

Blood samples taken for the research will be stored until analysed. With your permission, your samples will be stored anonymously, potentially for many years. They will be used for this study and future approved studies into the benefits of weight-loss surgery. If you decide to withdraw from the study, you can ask for your samples to be destroyed or for any information obtained from analysing your samples to be destroyed also.

What will happen to the results of the research study?

The first results of this study should become available about 3 years after the start of the study. We will publish relevant results in scientific journals, as well as presenting regular reports at various local, national and international level scientific meetings. You will not be identified in any report/publication. We will also present the results to the local patient support group and circulate a newsletter with the main findings of the study to all who participated. The main results of the study will be available in about 10 years. A report for the NHS will be written and the results will be used to influence future provision of surgery for obesity in the UK.

Who is Organising and Funding the Research?

The research is funded by National Institute for Health Research Health Technology Assessment Programme. The University of Bristol has overall responsibility for conduct of the study. The research is being organised and run on their behalf by the Clinical Trials and Evaluation Unit, University of Bristol.

Who has looked at the study?

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your safety, rights, wellbeing and dignity. This study has been reviewed and given a favourable opinion by South West - Frenchay Research Ethics Committee.

You can obtain general information on clinical research from the UK Clinical Research Collaboration (UKCRC) who produce a booklet called “Understanding Clinical Trials”. This provides in-depth information on the design and conduct of clinical trials and aims to answer the questions of those considering taking part.